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Quality Assurance Specialist

vor 2 Monaten

Frankfurt am Main, Hessen, Deutschland Cytiva Vollzeit

Be part of a dynamic team that drives innovation in life-changing therapeutics

Cytiva is a leading provider of solutions for the biopharmaceutical industry, and we're seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products and processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Complaint Management:
    • Receive, analyze, document, and respond to customer complaints in a timely manner.
    • Perform complaint trend analysis on a regular basis to inform operational reviews, management reviews, and complaint handling unit meetings.
  • Nonconformity and CAPA Management:
    • Manage non-conformance and CAPA (internal and external) processes, ensuring root cause analysis and effective implementation of robust action plans.
    • Follow up and verify CAPAs to ensure no recurrence and facilitate timely closure.
  • Internal Auditing:
  • Monitor QA KPIs and Escalate Trends:
    • Monitor quality assurance key performance indicators and escalate trends to ensure continuous improvement activities, such as process improvements and corrective actions, are implemented.

Requirements:

  • Bachelor's degree in engineering discipline (e.g., mechanical or chemical engineering).
  • Minimum 2-3 years of experience in quality assurance, preferably in the life sciences industry.
  • Good knowledge of using MS Office tools, such as MS Excel, for data analysis and management.
  • Ability to communicate effectively in both German and English (written and spoken).

Preferred Qualifications:

  • Knowledge and awareness of quality control methods and techniques in the manufacturing industry.
  • Technical knowledge of systems and devices used in the biopharmaceutical field.
  • ISO 9001 certification.

What We Offer:

  • Competitive salary.
  • Numerous benefits, including a company pension scheme and accident insurance.
  • Development opportunities at Cytiva and within the Danaher Group.
  • An international corporate environment in a rapidly growing industry.

Cytiva is a company that values diversity and the existence of similarities and differences in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.